The Use of Transient Elastography to Predict Clinical Decompensation in Patients With Early Cirrhosis

This is a prospective study designed to examine the role of transient elastography as a
predictor of clinical decompensation in patients with early cirrhosis. The study objective
is to determine if changes in measurements of liver stiffness with transient elastography
can identify patients that will have a more rapid progression of cirrhosis and the
development of clinical decompensation. The target population is patients with early stage,
well-compensated cirrhosis.

This study will attempt to determine if serial measurements of liver stiffness with
transient elastography in patients with early cirrhosis can identify patients at risk of
morbidity or mortality associated with hepatic decompensation.

For the Screening Visit, the following procedures will be performed:

1. Patient will read and sign informed consent. Subjects will be given sufficient time to
consider, ask questions, and sign the consent forms.

2. Patient will be assigned a subject number

3. Patient will be asked to provide demographic information

4. Patient will be asked to provide a complete medical history and laboratory evaluation

5. Physical examination including blood pressure, heart rate, height, and weight.

6. The following assessments will also be performed:

- Calculation of modified Child Pugh Score: Using the following biochemical
variables: Serum Albumin, Total Bilirubin, Serum Creatinine, and INR.

- MELD Score: Based on a continuous function of Bilirubin, INR, and Creatinine,
which uses a continuous variable ranging from 6-40.

7. 30cc of blood will be obtained, and serum frozen at -80C (freezer located in Dr.
Sigal's office) for up to 5 years. The blood will only be accessible to Dr. Sigal and
his research team. This blood may be analysed for known markers of liver disease,
markers that may be discovered in the future, and/or to identify new markers of liver
disease.

For the Follow-Up Visits the following procedures will be performed every 3 months for up to
2 years:

1. An interim medical history will be obtained, with particular attention to the
development of clinical decompensation (ascites, variceal bleeding hepatorenal
syndrome, overt hepatic encephalopathy).

2. Physical examination.

3. Measurement of liver stiffness using hepatic elastography.

4. 30cc of blood will be obtained, and serum frozen for future analyses as above.

Inclusion Criteria:

- Ambulatory patients with histologic or radiographic evidence of cirrhosis will be
screened for participation in the study.

- Able to provide informed consent

- MELD score <10

- No history of ascites, variceal bleeding, hepatorenal syndrome, overt hepatic
encephalopathy.

Exclusion Criteria:

- History of variceal bleeding, ascites, hepatorenal syndrome, or overt hepatic
encephalopathy

- Inability to provide informed consent

- Body mass index (BMI)>35